This brand name is authorized in Austria, Croatia, Cyprus, Estonia, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, Spain, UK.
The drug ADYNOVI contains one active pharmaceutical ingredient (API):
1
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UNII
5X3GF74R79 - ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
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Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life. Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa). The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line. Octocog alfa is then covalently conjugated with the PEG reagent. The PEG moiety is conjugated to octocog alfa to increase the plasma half-life. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ADYNOVI Powder and solvent for solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B02BD02 | Coagulation factor VIII | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 1762444, 1762455, 1762466, 1762477, 1762488, 1762499, 1762501, 1873111 |
| ES | Centro de información online de medicamentos de la AEMPS | 1171247002, 1171247006, 1171247010, 1171247014 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 144598, 189503, 524776 |
| FR | Base de données publique des médicaments | 61598943 |
| GB | Medicines & Healthcare Products Regulatory Agency | 387007, 387010, 387015, 387018 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1084806, 1084807, 1084808, 1084809, 1084810, 1084811, 1084812, 1084813, 1084814, 1084815, 1084816, 1084817, 1084818, 1084819 |
| NL | Z-Index G-Standaard | 14934590 |
| NL | Z-Index G-Standaard, PRK | 149292, 149306, 149314, 167940 |
| PL | Rejestru Produktów Leczniczych | 100400720, 100400908, 100400914, 100400920, 100465053 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W66273001, W66273002, W66274001, W66274002, W66275001, W66275002, W66276001, W66276002, W66507001, W66508001, W66509001, W68368001 |
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